Pfizer and BioNTech have submitted to the European Medicines Agency Ema the request for the green light for the administration of the anti-Covid Comirnaty vaccine * in adolescents aged 12 to 15 years. (continues)
The US giant and its German partner are asking the EMA to modify the conditional marketing authorization (Cma) issued for the vaccine in the European Union, so as to be able to extend its use also to 12-15 year olds. If the EMA approves, the modified Cma will be valid in all 27 EU member states, Pfizer and BioNTech explain. The two companies have already submitted a similar request to the US drug agency Fda for authorization for emergency use (Eue) in the 12-15 age group, and plan to request further changes in this regard to others as well. regulatory authorities globally.
The question put to EMA is based on data from a phase 3 clinical study that enrolled 2,260 participants aged 12 to 15 years. The results of the trial, announced on March 31 last – recall the two companies – showed a vaccine efficacy equal to 100% in participants with or without previous Sars-CoV-2 infection, and robust antibody responses. In addition, the vaccine was generally well tolerated in the study. Participants will continue to be monitored for an additional 2 years after the second dose to assess long-term protection and safety.